Hi, *Please reply to **[email protected]* <[email protected]>* and put cc to ** [email protected]* <[email protected]>* or feel free to contact me on 732-734-0711.*
Title: Validation Specialist - Senior Location: Plainsboro<javascript:Theme_OpenWindow(%22/BMS/Security/Controls/SecurityLocationDetailsScreen.ascx?PageTemplate=BeelineSelector&SecurityLocationID=df7659f2-d407-415c-b746-db6de49bbedf%22)>, NJ Duration:6 months Skills: • 6+ years experience • Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes • Follow SOPs and industry best practices • Conduct training on good documentation and good testing practices • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system • Review validation deliverables for projects which are contracted to third party suppliers • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues • Assist in planning, implementing, and documenting user acceptance testing • Review computerized systems validation documents such as: o Requirements Specification o Design Specification o CSV Risk Assessment o Test Plans o Test Summary Reports o Data Migration Plan o Pre/Post Executed Test Scripts o Traceability Matrix o Release to Production Statements • Direct and review testing • Provide guidance on quality issues that affect the integrity of the data or the system • Prepare validation summary and test summary reports • Obtain and respond to QA review • Participate in establishing standard quality and validation practices • Independently assess compliance practices and recommend corrective actions • Approve validated computer system related change requests • Monitor regulatory and inspection trends and advise the business on suitable action At least 6 years experience in software quality assurance in the pharmaceutical industry. Previous experience leading computer system validation efforts. Working knowledge of sales force automation, PDMA, 21 CFR Part 11 and related regulations & guidances. Hands on experience authoring computer system validation deliverables such as validation plans, test plans, test scripts and summary reports. Understanding of software development methodologies and concepts. *Excellent oral and written communication skills required.* -- Thanks & Regards Neal Smith Technical Recruiter Astoline Inc Office: 732-734-0711 Email: [email protected]
